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OpenTrials
Completed

NCT Number: NCT01871922

Atropine-effect During Propofol/Remifentanil Induction

Remifentanil is a widely used potent intravenous opioid with the advantage of having a short time of action. Compared to other opiates however remifentanil generates more intense hemodynamic side-effects. In ophthalmic surgery the specific anesthesiological challenges necessitate the administration of a combination of relatively high doses of analgesics on the one hand and a short time for postoperative recovery from anesthesia on the other. For these reasons, anesthetic management often consists of a combination of relatively high doses of propofol and remifentanil. A primary concern during this deep propofol/remifentanil anesthesia is preserving hemodynamic stability and adequate tissue oxygenation. Previous research of the investigators group has revealed that atropine has an exceptionally beneficial effect on hemodynamics as well as on tissue oxygenation. Therefore, the investigators hypothesize that administration of intravenous atropine during induction of propofol/remifentanil may have a positive effect on the hemodynamic profile and peripheral and cerebral tissue oxygenation during and after induction of anesthesia.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients requiring general anaesthesia;
  • Patient's age ≥ 18 years and older;
  • Patient and surgical procedure appropriate for treatment with either sufentanil or remifentanil.

Exclusion criteria

  • Patient's refusal;
  • Pregnancy;
  • Patient's age < 18 years;
  • Patients in which atropine is contra-indicated, such as severe aortic valve stenosis, hypertrophic cardiomyopathy or coronary artery disease.

Treatment and study plan

Placebo

Drug

Saline

Other names: Saline

Atropine

Drug

Atropine

Primary outcomes

  1. Cardiac output

    Time frame: During anesthesia

  2. Peripheral tissue oxygen saturation

    Time frame: During anesthesia

  3. Cerebral tissue oxygen saturation

    Time frame: During anesthesia

Secondary outcomes

  1. Heart rate

    Time frame: During anesthesia

  2. Mean arterial blood pressure

    Time frame: During anesthesia

  3. Systemic vascular resistance

    Time frame: During anesthesia

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Evaluation of the Effects of the Addition of Atropine During Propofol/Remifentanil Induction of Anesthesia on Hemodynamics, Microvascular Blood Flow and Tissue Oxygenenation in Patients Undergoing Ophthalmic Surgery

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 7, 2013
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.